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Medical Communication - Volume 22, Issue

I'm sitting down to write this having just returned from the DIA Euro meeting in Amsterdam. As always, it was a busy and successful meeting, with many ‘themes’ of presentations being given at once. However, this year there were many presentations…

Potential implications of wider data transparency in medical communications - Volume 22, Issue

The current medical communication environment is characterised by growing calls for increased data transparency. There are ongoing concerns about the selective publication of trial results and the potential impact on use of medicines by prescribers…

Post-approval regulatory writing – How different is it from writing pre-approval documents? - Volume 23, Issue

Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…

Gained in Translation - Volume 24, Issue

Editorial Welcome to the Translation Section editorial! What we call ‘lay-friendliness’ is a key characteristic of Patient Information Sheets (PIS), which are tightly regulated on a European level to guarantee a comprehensible document that…

Journal Watch - Volume 21, Issue

Readability of informed consent forms, sponsor participation in industry trials, and conflict of interest disclosure. Informed consent is a crucial feature of clinical research trials. Guidelines on developing an informed consent form urge writers…

Regulatory Writing - Volume 22, Issue

The European Medicine Agency's draft policy on the publication of clinical trial data for consultation (POLICY/0070, EMA/240810/2013) is causing quite a stir. The draft policy provides for the publication of large parts of the clinical study reports…

EU sourcing requirements for animal-derived materials - Volume 31, Issue

Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…

Lay titles for clinical trials: Is industry achieving the balance? - Volume 32, Issue

Titles of clinical trials may directly influence whether patients, caretakers, or healthcare professionals will want to obtain more information about the trial. Major clinical trial registries require lay titles (referred to as “brief” or “public”…

Science journalism: In search of a new identity - Volume 26, Issue

Abstract Science journalism is undergoing a major transition due to changes in the relationship between science and society and dissemin - ation via digital and connective technologies, as is the case with other branches of journalism. The changes…

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

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Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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